Prospective Observational Study to Monitor and Assess the Safety of Amvuttra® [Vutrisiran] in a Real-World Cohort of hATTR Amyloidosis Patients

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/199013
• EU PAS number:
  EUPAS108904
• Study ID:
  199013
• Official title and acronym:
  Prospective Observational Study to Monitor and Assess the Safety of Amvuttra® [Vutrisiran] in a Real-World Cohort of hATTR Amyloidosis Patients
• DARWIN EU® study:
  No
• Study countries:
  Brazil

  Bulgaria

  Denmark

  France

  Germany

  Israel

  Italy

  Netherlands

  Portugal

  Spain

  Taiwan

  United Kingdom

  United States
• Study description:
  This is a multinational, non-interventional, observational study based on secondary use of data and conducted over a period of 10 years to evaluate the safety of vutrisiran in hATTR amyloidosis participants exposed to vutrisiran under real-world conditions.
• Study status:
  Planned

Research institutions and networks

Institutions

IQVIA

United Kingdom

Multiple centres: 41 centres involved in the study

Study timelines

Date when funding contract was signed

Planned: 29/02/2024

Study start date

Planned: 29/02/2024

Date of final study report

Planned: 31/12/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Alnylam

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)